FDA 510(k)

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES

K-Number: K051301 · 2005-08-30

Decision Date2005-08-30

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES 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 2005-08-30 under 510(k) number K051301. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES?

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2005-08-30. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K051301.

When did PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES receive FDA 510(k) clearance?

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES received FDA 510(k) clearance on 2005-08-30, under 510(k) number K051301.

Who is the listed applicant for PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES?

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 PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES?

The FDA product code for PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES is GDW.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ethicon Endo-Surgery, Inc. as applicant

K111195VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS K110385ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER K101520ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH K102632ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER K093896ETHICON ENDO SURGERY SLOTTED ANOSCOPE K091259ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS

View all 111 devices →

Related Devices (Code: GDW)

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.