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FDA 510(k)

J105 JAMES SURGICAL SYSTEM I/A PACK

K-Number: K911932 · 1991-08-26

ApplicantO.R. Specialties, Inc.
Decision Date1991-08-26
Product CodeGZX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

J105 JAMES SURGICAL SYSTEM I/A PACK is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Specialties, Inc.. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K911932. The device is classified under product code GZX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J105 JAMES SURGICAL SYSTEM I/A PACK?

J105 JAMES SURGICAL SYSTEM I/A PACK is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is O.R. Specialties, Inc.. The 510(k) number is K911932.

When did J105 JAMES SURGICAL SYSTEM I/A PACK receive FDA 510(k) clearance?

J105 JAMES SURGICAL SYSTEM I/A PACK received FDA 510(k) clearance on 1991-08-26, under 510(k) number K911932.

Who is the listed applicant for J105 JAMES SURGICAL SYSTEM I/A PACK?

The FDA 510(k) record lists O.R. Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for J105 JAMES SURGICAL SYSTEM I/A PACK?

The FDA product code for J105 JAMES SURGICAL SYSTEM I/A PACK is GZX.

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Other records listing O.R. Specialties, 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.

K942607LAPAROSCOPIC SCISSORS (DISPOSABLE)K923630PHACO NEEDLES 1000-R & 1000-O NEEDLESK925671DISPOSABLE SCLERAL PLUGSK923887JACK'S VENT TUBESK923774DISPOSABLE ENDOILLUMINATORK922355POLLY'S VITREOUS SCISSORS J-225-S

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Related Devices (Code: GZX)

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.

K932169MICROSURGICAL INSTRUMENTSAmerican Russian Medical Services, Inc.K926048CLARUS ENDOSCOPIC BALL PROBEClarus Medical Systems, Inc.K890216MICROSURGICAL KERATOMEKinetic Medical ProductsK873933RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUMDowns Surgical , Ltd.K873934RANGE OF CROCODILE ACTION INSTRUMENTSDowns Surgical , Ltd.K862971MICRA MICROSURGICAL INSTRUMENTSCordis 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.

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