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FDA 510(k)

GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE

K-Number: K801465 · 1980-07-28

ApplicantEdward Weck, Inc.
Decision Date1980-07-28
Product CodeHNR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801465. The device is classified under product code HNR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE?

GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Edward Weck, Inc.. The 510(k) number is K801465.

When did GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE receive FDA 510(k) clearance?

GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801465.

Who is the listed applicant for GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE?

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

What is the FDA product code for GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE?

The FDA product code for GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE is HNR.

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Other records listing Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

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Related Devices (Code: HNR)

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.

K022835STEPHENS DISPOSABLE FORCEPSStephens InstrumentsK895434ALCON FOLDING FORCEPSAlcon LaboratoriesK891487SOFT LENS FOLDING BLOCKWestern Medical Products, Inc.K893199PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTRAllergan Medical OpticsK885230MCDONALD FOLDING FORCEPSAlcon LaboratoriesK881049BRADBURY INTRAOCULAR RETINAL KIT CAT #200Microline Pentax, 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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