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FDA 510(k)

BLADE, 20 ANGLE/MICRO BLADE HOLDER

K-Number: K781716 · 1978-10-24

ApplicantEdward Weck, Inc.
Decision Date1978-10-24
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLADE, 20 ANGLE/MICRO BLADE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781716. 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 BLADE, 20 ANGLE/MICRO BLADE HOLDER?

BLADE, 20 ANGLE/MICRO BLADE HOLDER is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Edward Weck, Inc.. The 510(k) number is K781716.

When did BLADE, 20 ANGLE/MICRO BLADE HOLDER receive FDA 510(k) clearance?

BLADE, 20 ANGLE/MICRO BLADE HOLDER received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781716.

Who is the listed applicant for BLADE, 20 ANGLE/MICRO BLADE HOLDER?

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

What is the FDA product code for BLADE, 20 ANGLE/MICRO BLADE HOLDER?

The FDA product code for BLADE, 20 ANGLE/MICRO BLADE HOLDER is GES.

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Other records listing Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

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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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