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FDA 510(k)

BLADES, SURGICAL, STERILE

K-Number: K770798 · 1977-05-06

ApplicantLukens Corp.
Decision Date1977-05-06
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLADES, SURGICAL, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Lukens Corp.. It received FDA 510(k) clearance on 1977-05-06 under 510(k) number K770798. 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 BLADES, SURGICAL, STERILE?

BLADES, SURGICAL, STERILE is a medical device that received FDA 510(k) clearance on 1977-05-06. The listed applicant is Lukens Corp.. The 510(k) number is K770798.

When did BLADES, SURGICAL, STERILE receive FDA 510(k) clearance?

BLADES, SURGICAL, STERILE received FDA 510(k) clearance on 1977-05-06, under 510(k) number K770798.

Who is the listed applicant for BLADES, SURGICAL, STERILE?

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

What is the FDA product code for BLADES, SURGICAL, STERILE?

The FDA product code for BLADES, SURGICAL, STERILE is GES.

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Other records listing Lukens Corp. 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.

K880230SIXALYZERK800102STANFORD STERILE LAP SPONGESK792471STANFORD STERILE LAP SPONGESK791495LUKENS BONE WAX (GAMMA RADIATION)K770797TRAY, CATHETERIZATION W/FOLEY, STERILEK770795SHAVE PREP SET

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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

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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