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FDA 510(k)

GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)

K-Number: K893869 · 1989-08-03

ApplicantAdept-Med Intl., Inc.
Decision Date1989-08-03
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Adept-Med Intl., Inc.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K893869. 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 GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)?

GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Adept-Med Intl., Inc.. The 510(k) number is K893869.

When did GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) receive FDA 510(k) clearance?

GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) received FDA 510(k) clearance on 1989-08-03, under 510(k) number K893869.

Who is the listed applicant for GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)?

The FDA 510(k) record lists Adept-Med Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)?

The FDA product code for GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) is GAD.

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Other records listing Adept-Med Intl., 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.

K935636GRAVESPECK893871GOOTT BALFOUR BLADEK893870ADAMS BREAST IMPLANT PROTECTORK870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206K802806VISECERA RETAINER

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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