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FDA 510(k)

I.M.A. RETRACTOR

K-Number: K881159 · 1988-04-05

ApplicantT. Korossurgical Instruments Corp.
Decision Date1988-04-05
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I.M.A. RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is T. Korossurgical Instruments Corp.. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K881159. 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 I.M.A. RETRACTOR?

I.M.A. RETRACTOR is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is T. Korossurgical Instruments Corp.. The 510(k) number is K881159.

When did I.M.A. RETRACTOR receive FDA 510(k) clearance?

I.M.A. RETRACTOR received FDA 510(k) clearance on 1988-04-05, under 510(k) number K881159.

Who is the listed applicant for I.M.A. RETRACTOR?

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

What is the FDA product code for I.M.A. RETRACTOR?

The FDA product code for I.M.A. RETRACTOR is GAD.

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Other records listing T. Korossurgical Instruments Corp. 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.

K001915GRAFT MARKER RINGK002755NON-ABSORBING STERNATOMY MONOFILAMENT SUTUREK954016VIDEOSCOPE W/IRRIGATION SHEATHK953998DISCETOME TISSUE ASPIRATORK954052ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTESK954014PERCUTANEOUS DISCECTOMY CANNULA SYSTEM

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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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