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FDA 510(k)

SELF-RETAINING SOFT TISSUE RETRACTOR

K-Number: K882075 · 1988-06-16

ApplicantKarlin Technology, Inc.
Decision Date1988-06-16
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SELF-RETAINING SOFT TISSUE RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Karlin Technology, Inc.. It received FDA 510(k) clearance on 1988-06-16 under 510(k) number K882075. 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 SELF-RETAINING SOFT TISSUE RETRACTOR?

SELF-RETAINING SOFT TISSUE RETRACTOR is a medical device that received FDA 510(k) clearance on 1988-06-16. The listed applicant is Karlin Technology, Inc.. The 510(k) number is K882075.

When did SELF-RETAINING SOFT TISSUE RETRACTOR receive FDA 510(k) clearance?

SELF-RETAINING SOFT TISSUE RETRACTOR received FDA 510(k) clearance on 1988-06-16, under 510(k) number K882075.

Who is the listed applicant for SELF-RETAINING SOFT TISSUE RETRACTOR?

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

What is the FDA product code for SELF-RETAINING SOFT TISSUE RETRACTOR?

The FDA product code for SELF-RETAINING SOFT TISSUE RETRACTOR is GAD.

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Other records listing Karlin Technology, Inc. as applicant

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K903969SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RETK893203BONE SCREWK893201BONE PLATEK882525SPINAL MICROKNIFEK882519X-RAY MARKERK882073SPINAL NEEDLE

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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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