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FDA 510(k)

RETRACTOR

K-Number: K941448 · 1994-04-15

ApplicantTechnovations
Decision Date1994-04-15
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Technovations. It received FDA 510(k) clearance on 1994-04-15 under 510(k) number K941448. 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 RETRACTOR?

RETRACTOR is a medical device that received FDA 510(k) clearance on 1994-04-15. The listed applicant is Technovations. The 510(k) number is K941448.

When did RETRACTOR receive FDA 510(k) clearance?

RETRACTOR received FDA 510(k) clearance on 1994-04-15, under 510(k) number K941448.

Who is the listed applicant for RETRACTOR?

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

What is the FDA product code for RETRACTOR?

The FDA product code for RETRACTOR is GAD.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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