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FDA 510(k)

RETRACTOR, SURGICAL

K-Number: K852330 · 1985-06-27

ApplicantScholten Surgical Instruments, Inc.
Decision Date1985-06-27
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RETRACTOR, SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Scholten Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1985-06-27 under 510(k) number K852330. 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, SURGICAL?

RETRACTOR, SURGICAL is a medical device that received FDA 510(k) clearance on 1985-06-27. The listed applicant is Scholten Surgical Instruments, Inc.. The 510(k) number is K852330.

When did RETRACTOR, SURGICAL receive FDA 510(k) clearance?

RETRACTOR, SURGICAL received FDA 510(k) clearance on 1985-06-27, under 510(k) number K852330.

Who is the listed applicant for RETRACTOR, SURGICAL?

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

What is the FDA product code for RETRACTOR, SURGICAL?

The FDA product code for RETRACTOR, SURGICAL is GAD.

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Other records listing Scholten Surgical Instruments, 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.

K072051NOVATOME, MODEL: SU101-50K900405SCHOLTEN FRAMEK852331SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHICK852119TEMPORARY PACEMAKER GROUND WIREK852332TABLE ACCESSORIES, OPERATING ROOMK852120FORCEPS, BIOPSY(NON RIGID)

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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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