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FDA 510(k)

DISPOSABLE SKIN STAPLER

K-Number: K830768 · 1983-04-12

ApplicantSurgeons Choice, Inc.
Decision Date1983-04-12
Product CodeFZQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SKIN STAPLER is the device name listed in this FDA 510(k) record. The listed applicant is Surgeons Choice, Inc.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830768. The device is classified under product code FZQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SKIN STAPLER?

DISPOSABLE SKIN STAPLER is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Surgeons Choice, Inc.. The 510(k) number is K830768.

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

DISPOSABLE SKIN STAPLER received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830768.

Who is the listed applicant for DISPOSABLE SKIN STAPLER?

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

What is the FDA product code for DISPOSABLE SKIN STAPLER?

The FDA product code for DISPOSABLE SKIN STAPLER is FZQ.

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 Surgeons Choice, 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.

K851121PI-PHEUMO INTESTINAL INSTRUMENT SETK851122PI-PNEUMO INTESTINAL STAPLING CARTRIDGEK843399SURGEONS CHOICE PI VASCULAR STAPLINGK823776PI-PNEUMO-INTESTINAL INSTRUMENT SETK813170ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER

Related Devices (Code: FZQ)

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.

K884783RANEY CLIPAlto Development Corp.K873744LEUKOCLIP(R)Beiersdorf, Inc.K830704ONE TIME DISPOSABLE SKIN STAPLERAcme United Corp.K822963SURGICAL PRODUCTS, SKIN STAPLE REMOVERTemp-Stik Corp.K822145COMPLETERichard-Allan Medical Ind., 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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