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FDA 510(k)

VAGINAL RETRACTOR

K-Number: K780349 · 1978-03-14

ApplicantEdward Weck, Inc.
Decision Date1978-03-14
Product CodeHDL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VAGINAL RETRACTOR 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 1978-03-14 under 510(k) number K780349. The device is classified under product code HDL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAGINAL RETRACTOR?

VAGINAL RETRACTOR is a medical device that received FDA 510(k) clearance on 1978-03-14. The listed applicant is Edward Weck, Inc.. The 510(k) number is K780349.

When did VAGINAL RETRACTOR receive FDA 510(k) clearance?

VAGINAL RETRACTOR received FDA 510(k) clearance on 1978-03-14, under 510(k) number K780349.

Who is the listed applicant for VAGINAL RETRACTOR?

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 VAGINAL RETRACTOR?

The FDA product code for VAGINAL RETRACTOR is HDL.

Related Clinical Trials

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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: HDL)

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.

K891038VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKYZinnanti Surgical Instruments, 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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