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FDA 510(k)

SABLE BLADES

K-Number: K863885 · 1986-10-24

ApplicantSable Industries
Decision Date1986-10-24
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SABLE BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Sable Industries. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863885. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SABLE BLADES?

SABLE BLADES is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Sable Industries. The 510(k) number is K863885.

When did SABLE BLADES receive FDA 510(k) clearance?

SABLE BLADES received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863885.

Who is the listed applicant for SABLE BLADES?

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

What is the FDA product code for SABLE BLADES?

The FDA product code for SABLE BLADES is GES.

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Related Devices (Code: GES)

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.

K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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