FDA 510(k)

CHISEL (OSTEOTOME, GOUGE, ETC.)

K-Number: K864775 · 1987-02-12

ApplicantNew England Surgical Instrument Corp.

Decision Date1987-02-12

Product CodeEMM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CHISEL (OSTEOTOME, GOUGE, ETC.) is the device name listed in this FDA 510(k) record. The listed applicant is New England Surgical Instrument Corp.. It received FDA 510(k) clearance on 1987-02-12 under 510(k) number K864775. The device is classified under product code EMM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHISEL (OSTEOTOME, GOUGE, ETC.)?

CHISEL (OSTEOTOME, GOUGE, ETC.) is a medical device that received FDA 510(k) clearance on 1987-02-12. The listed applicant is New England Surgical Instrument Corp.. The 510(k) number is K864775.

When did CHISEL (OSTEOTOME, GOUGE, ETC.) receive FDA 510(k) clearance?

CHISEL (OSTEOTOME, GOUGE, ETC.) received FDA 510(k) clearance on 1987-02-12, under 510(k) number K864775.

Who is the listed applicant for CHISEL (OSTEOTOME, GOUGE, ETC.)?

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

What is the FDA product code for CHISEL (OSTEOTOME, GOUGE, ETC.)?

The FDA product code for CHISEL (OSTEOTOME, GOUGE, ETC.) is EMM.

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Other records listing New England Surgical Instrument Corp. as applicant

K895337ELECTROSURGICAL COAGULATION SUCTION TUBE K895331ELECTROSURGICAL ELECTRODE K883963RANEY AND LEROY-RANEY SCALP CLIP K883396HANDSWITCHING MONOPOLAR PENCIL K880863BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 K880859SURGICAL BURS

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Related Devices (Code: EMM)

K963897STERI-OSS SINUS AUGMENTATION KITSteri-Oss, Inc.K851714820/1 TO 820/51 VARIOUS TYPES BONE RONGEURSArtiberia K760959SURGICAL CHISELAmerican Safety Equipment Corp.

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.