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FDA 510(k)

TEW BYPASS INSTRUMENTS & DISSECTING KIT

K-Number: K791703 · 1979-10-04

ApplicantEdward Weck, Inc.
Decision Date1979-10-04
Product CodeGDI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TEW BYPASS INSTRUMENTS & DISSECTING KIT 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 1979-10-04 under 510(k) number K791703. The device is classified under product code GDI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEW BYPASS INSTRUMENTS & DISSECTING KIT?

TEW BYPASS INSTRUMENTS & DISSECTING KIT is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Edward Weck, Inc.. The 510(k) number is K791703.

When did TEW BYPASS INSTRUMENTS & DISSECTING KIT receive FDA 510(k) clearance?

TEW BYPASS INSTRUMENTS & DISSECTING KIT received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791703.

Who is the listed applicant for TEW BYPASS INSTRUMENTS & DISSECTING KIT?

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 TEW BYPASS INSTRUMENTS & DISSECTING KIT?

The FDA product code for TEW BYPASS INSTRUMENTS & DISSECTING KIT is GDI.

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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: GDI)

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.

K896383DISPOSABLE EXTERNAL CLAMPSGalenica Enterprises, Inc.K850288HEPATIC PARENCHYMAL SUCTION DISSECTORBeecher Medical Diagnostic InstrumentationK831912ROUND-BEEHIVE- DISSECTORS 3/8Ormed Mfg., Inc.K822569TYMPANOPLASTY & SKIN DISSECTORSKelleher Corp.K803292FIELD SUCTION DISSECTORV. Mueller O.V. Baxter Healthcare Corp.K791870DISPOSABLE SPECIALITY SPONGESCarwild Corp.

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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