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FDA 510(k)

HEISS RETRACTOR

K-Number: K771191 · 1977-07-11

ApplicantEdward Weck, Inc.
Decision Date1977-07-11
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEISS 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 1977-07-11 under 510(k) number K771191. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEISS RETRACTOR?

HEISS RETRACTOR is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Edward Weck, Inc.. The 510(k) number is K771191.

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

HEISS RETRACTOR received FDA 510(k) clearance on 1977-07-11, under 510(k) number K771191.

Who is the listed applicant for HEISS 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 HEISS RETRACTOR?

The FDA product code for HEISS RETRACTOR is GAD.

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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: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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