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FDA 510(k)

ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508

K-Number: K994015 · 2000-03-15

ApplicantSurgin Surgical Instrumentation, Inc.
Decision Date2000-03-15
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 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 2000-03-15 under 510(k) number K994015. 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 ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508?

ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 is a medical device that received FDA 510(k) clearance on 2000-03-15. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K994015.

When did ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 receive FDA 510(k) clearance?

ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 received FDA 510(k) clearance on 2000-03-15, under 510(k) number K994015.

Who is the listed applicant for ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508?

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 ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508?

The FDA product code for ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 is HNO.

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Other records listing Surgin Surgical Instrumentation, Inc. as applicant

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K082110DUAL SYRINGE HOLDERK033236PRIZM KERATOME BLADE, MODEL MK8512M2K033182PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BDK011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CBK980849SURGIN KITK954238SURGIN GENISIS HANDPIECE

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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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