FDA 510(k)

SURGIN KIT

K-Number: K980849 · 1998-07-09

ApplicantSurgin Surgical Instrumentation, Inc.

Decision Date1998-07-09

Product CodeMSR

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SURGIN KIT 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 1998-07-09 under 510(k) number K980849. The device is classified under product code MSR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIN KIT?

SURGIN KIT is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K980849.

When did SURGIN KIT receive FDA 510(k) clearance?

SURGIN KIT received FDA 510(k) clearance on 1998-07-09, under 510(k) number K980849.

Who is the listed applicant for SURGIN KIT?

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 SURGIN KIT?

The FDA product code for SURGIN KIT is MSR.

Related Clinical Trials

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.

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Other records listing Surgin Surgical Instrumentation, Inc. as applicant

K082110DUAL SYRINGE HOLDER K033236PRIZM KERATOME BLADE, MODEL MK8512M2 K033182PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD K011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB K994015ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 K954238SURGIN GENISIS HANDPIECE

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Related Devices (Code: MSR)

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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.