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FDA 510(k)

SUTURE HANDLER

K-Number: K934173 · 1993-12-01

ApplicantSurgin Surgical Instrumentation, Inc.
Decision Date1993-12-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUTURE HANDLER is the device name listed in this FDA 510(k) record. The listed applicant is Surgin Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1993-12-01 under 510(k) number K934173. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE HANDLER?

SUTURE HANDLER is a medical device that received FDA 510(k) clearance on 1993-12-01. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K934173.

When did SUTURE HANDLER receive FDA 510(k) clearance?

SUTURE HANDLER received FDA 510(k) clearance on 1993-12-01, under 510(k) number K934173.

Who is the listed applicant for SUTURE HANDLER?

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

What is the FDA product code for SUTURE HANDLER?

The FDA product code for SUTURE HANDLER is GCJ.

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Other records listing Surgin Surgical Instrumentation, 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.

K082110DUAL SYRINGE HOLDERK033236PRIZM KERATOME BLADE, MODEL MK8512M2K033182PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BDK011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CBK994015ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508K980849SURGIN KIT

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Related Devices (Code: GCJ)

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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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