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FDA 510(k)

ROWE SHOULDER INSTR. FOR BANKHART REPAIR

K-Number: K820344 · 1982-03-08

ApplicantNew England Surgical Instrument Corp.
Decision Date1982-03-08
Product CodeHTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROWE SHOULDER INSTR. FOR BANKHART REPAIR is the device name listed in this FDA 510(k) record. The listed applicant is New England Surgical Instrument Corp.. It received FDA 510(k) clearance on 1982-03-08 under 510(k) number K820344. The device is classified under product code HTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROWE SHOULDER INSTR. FOR BANKHART REPAIR?

ROWE SHOULDER INSTR. FOR BANKHART REPAIR is a medical device that received FDA 510(k) clearance on 1982-03-08. The listed applicant is New England Surgical Instrument Corp.. The 510(k) number is K820344.

When did ROWE SHOULDER INSTR. FOR BANKHART REPAIR receive FDA 510(k) clearance?

ROWE SHOULDER INSTR. FOR BANKHART REPAIR received FDA 510(k) clearance on 1982-03-08, under 510(k) number K820344.

Who is the listed applicant for ROWE SHOULDER INSTR. FOR BANKHART REPAIR?

The FDA 510(k) record lists New England Surgical Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROWE SHOULDER INSTR. FOR BANKHART REPAIR?

The FDA product code for ROWE SHOULDER INSTR. FOR BANKHART REPAIR is HTD.

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Other records listing New England Surgical Instrument Corp. 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.

K895331ELECTROSURGICAL ELECTRODEK895337ELECTROSURGICAL COAGULATION SUCTION TUBEK883963RANEY AND LEROY-RANEY SCALP CLIPK883396HANDSWITCHING MONOPOLAR PENCILK880863BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200K880859SURGICAL BURS

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Related Devices (Code: HTD)

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.

K051281THE NEEDLE CATCHERE.D.Medical , Ltd.K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPTitan Mfg., Inc.K974594SEMKIN BIPOLAR FORCEPTitan Mfg., Inc.K974593SEMKIN INSULATED BIPOLAR FORCEPTitan Mfg., Inc.K913964MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPSMarlo Surgical TechnologyK911180CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPSNorthgate Technologies, 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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