Surgical Instruments for the US Healthcare Market
Pintech Instruments is an ISO 13485 certified surgical instruments manufacturer in Sialkot, Pakistan supplying the US market since 2008. We are a direct factory source — no agents, no middlemen — for US surgical distributors, hospital GPOs, ambulatory surgical centres (ASCs), dental supply companies, and OEM private label brands looking to source precision instruments at factory-direct pricing.
The United States is Pakistan's single largest export market for surgical instruments, accounting for approximately 27% of Pakistan's $420 million annual surgical instrument export. Buyers from coast to coast — from large IDNs like HCA and CommonSpirit to independent ASCs and boutique surgical distributors — source from Sialkot manufacturers like Pintech to compete on cost without sacrificing quality.
FDA Compliance Documentation for US Buyers
Surgical instruments imported into the US are regulated by the FDA under 21 CFR. Most general surgical instruments — forceps, scissors, needle holders, retractors, scalpels, dental instruments — are classified as Class I 510(k) exempt devices, meaning they can be imported without premarket notification. We provide complete compliance documentation with every order.
Most Ordered by US Buyers
| General Surgical Instruments | Haemostatic forceps (Kelly, Mosquito, Crile), tissue forceps, scissors (Mayo, Metzenbaum, iris), needle holders (Mayo-Hegar, Castroviejo), retractors (Weitlaner, Gelpi, Army-Navy), scalpel handles. Core ASC and OR instrument sets. |
| Ophthalmology Instruments | Iris scissors, speculum, lens loop, needle holders — widely sourced by US eye surgery centres and ophthalmology distributors. |
| Dental Instruments (American Pattern) | Extraction forceps (upper and lower, universal), root tip elevators, periotomes, scalers, gracey curettes, exploration probes. Direct drop-in replacements for major US dental brands. |
| OEM Procedure Trays | Custom procedure-specific trays assembled to your instrument list, sterilisation pouch or rigid container, labelled with your brand — ready for single-use or reprocessing. |
| Veterinary Instruments | Professional veterinary forceps, castration instruments, hoof tools, marking equipment for US veterinary distributors and agricultural supply companies. |
Why US Distributors Source from Pintech
FAQ — Importing Surgical Instruments from Pakistan to the USA
▼ Are your surgical instruments FDA approved for import into the USA?
Yes. We hold FDA Establishment Registration which authorises us to export surgical instruments to the United States. Most general surgical instruments (forceps, scissors, needle holders, retractors) are classified as Class I exempt devices under 21 CFR — they do not require 510(k) premarket notification. We provide our FDA registration number and 510(k) exemption confirmation with every order.
▼ Can you supply instruments under our US brand name (OEM / private label)?
Yes. We manufacture under private label for multiple US distributors. We laser-engrave your catalogue numbers and brand name onto instruments, supply your custom packaging, and provide all FDA and ISO documentation referencing your brand. OEM orders typically require 4–6 weeks lead time.
▼ What is the HS code for surgical instruments imported into the USA and what are the duties?
Most surgical instruments are classified under HS Code 9018. The general duty rate for surgical instruments from Pakistan entering the US is 0% under most classifications — making Pakistan one of the most cost-effective sources globally. We provide accurate HS codes for every product on commercial invoices.
▼ What is your minimum order quantity for US wholesale accounts?
We have no fixed minimum order quantity for standard catalogue items. Trial orders of 10–25 pieces per SKU are available to allow US buyers to evaluate quality before committing to larger quantities. Larger GPO or distributor orders qualify for volume pricing.
▼ How long does shipping take to the United States?
Air freight to US ports (New York, Los Angeles, Chicago, Miami) takes 5–7 business days via DHL Express or FedEx International Priority. Sea freight is available for large volume orders. All shipments include full export documentation: commercial invoice, packing list, certificate of origin, and FDA registration documentation.
▼ Do you supply against GPO contracts and hospital system procurement?
Yes. We supply against GPO frameworks and hospital system procurement requirements. We provide all documentation typically required including ISO 13485 certificates, FDA registration, material test certificates, lot traceability records, and pricing structures compatible with GPO contract requirements.
Request Your USA Wholesale Pricing
Send us your instrument list — we respond with a quotation within 24 hours, Monday–Saturday. Sample orders available before bulk commitment.