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FDA 510(k)

DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS

K-Number: K953012 · 1995-07-12

ApplicantBoston Surgical Products, Inc.
Decision Date1995-07-12
Product CodeGFA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Surgical Products, Inc.. It received FDA 510(k) clearance on 1995-07-12 under 510(k) number K953012. The device is classified under product code GFA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS?

DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS is a medical device that received FDA 510(k) clearance on 1995-07-12. The listed applicant is Boston Surgical Products, Inc.. The 510(k) number is K953012.

When did DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS receive FDA 510(k) clearance?

DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS received FDA 510(k) clearance on 1995-07-12, under 510(k) number K953012.

Who is the listed applicant for DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS?

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

What is the FDA product code for DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS?

The FDA product code for DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS is GFA.

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Other records listing Boston Surgical Products, 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.

K972311MODEL 20 BIPOLAR COAGULATORK972350MODEL 50 BIPOLAR COAGULATORK944947ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSK950375DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATORK951912DISOPOSABLE & RESUABLE MONPOLAR CORDK951269DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL

View all 17 devices →

Related Devices (Code: GFA)

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.

K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyincK954483STRYKER SAGITTAL SAW ATTACHMENTStryker InstrumentsK955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyincK950403SURGICAL SAW BLADESTransidyne General Corp.K940501RE-SHARPENABLE SAW BLADESAdven MedicalK933595BUR, SURGICAL, GENERAL & PLASTIC SURGERYOmega Surgical Instruments, Inc.

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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