FDA 510(k)

PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES

K-Number: K002849 · 2000-10-18

Decision Date2000-10-18

Product CodeHNO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corp. It received FDA 510(k) clearance on 2000-10-18 under 510(k) number K002849. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES?

PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES is a medical device that received FDA 510(k) clearance on 2000-10-18. The listed applicant is Surgical Specialties Corp. The 510(k) number is K002849.

When did PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES receive FDA 510(k) clearance?

PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES received FDA 510(k) clearance on 2000-10-18, under 510(k) number K002849.

Who is the listed applicant for PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES?

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

What is the FDA product code for PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES?

The FDA product code for PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES is HNO.

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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.