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FDA 510(k)

SKIN STAPLER HANDLE 523700/CARTRIDGES

K-Number: K801445 · 1980-07-14

ApplicantEdward Weck, Inc.
Decision Date1980-07-14
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKIN STAPLER HANDLE 523700/CARTRIDGES is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801445. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN STAPLER HANDLE 523700/CARTRIDGES?

SKIN STAPLER HANDLE 523700/CARTRIDGES is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Edward Weck, Inc.. The 510(k) number is K801445.

When did SKIN STAPLER HANDLE 523700/CARTRIDGES receive FDA 510(k) clearance?

SKIN STAPLER HANDLE 523700/CARTRIDGES received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801445.

Who is the listed applicant for SKIN STAPLER HANDLE 523700/CARTRIDGES?

The FDA 510(k) record lists Edward Weck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKIN STAPLER HANDLE 523700/CARTRIDGES?

The FDA product code for SKIN STAPLER HANDLE 523700/CARTRIDGES is GAG.

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Other records listing Edward Weck, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

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Related Devices (Code: GAG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLCK251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLCK234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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