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FDA 510(k)

PROXIMATE DISPOSABLE SKIN STAPLER

K-Number: K970079 · 1997-03-11

ApplicantEthicon Endo-Surgery, Inc.
Decision Date1997-03-11
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROXIMATE DISPOSABLE SKIN STAPLER is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K970079. 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 PROXIMATE DISPOSABLE SKIN STAPLER?

PROXIMATE DISPOSABLE SKIN STAPLER is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K970079.

When did PROXIMATE DISPOSABLE SKIN STAPLER receive FDA 510(k) clearance?

PROXIMATE DISPOSABLE SKIN STAPLER received FDA 510(k) clearance on 1997-03-11, under 510(k) number K970079.

Who is the listed applicant for PROXIMATE DISPOSABLE SKIN STAPLER?

The FDA 510(k) record lists Ethicon Endo-Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROXIMATE DISPOSABLE SKIN STAPLER?

The FDA product code for PROXIMATE DISPOSABLE SKIN STAPLER is GAG.

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Other records listing Ethicon Endo-Surgery, 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.

K111195VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADSK110385ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTERK101520ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RHK102632ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLERK093896ETHICON ENDO SURGERY SLOTTED ANOSCOPEK091259ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS

View all 111 devices →

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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