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FDA 510(k)

SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM

K-Number: K926127 · 1993-06-24

ApplicantLife Medical Sciences, Inc.
Decision Date1993-06-24
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Medical Sciences, Inc.. It received FDA 510(k) clearance on 1993-06-24 under 510(k) number K926127. 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 SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM?

SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM is a medical device that received FDA 510(k) clearance on 1993-06-24. The listed applicant is Life Medical Sciences, Inc.. The 510(k) number is K926127.

When did SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM receive FDA 510(k) clearance?

SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM received FDA 510(k) clearance on 1993-06-24, under 510(k) number K926127.

Who is the listed applicant for SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM?

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

What is the FDA product code for SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM?

The FDA product code for SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM is GAG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Life Medical Sciences, 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.

K980563SKAR-KARE SHEETK942526SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM

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

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

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