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FDA 510(k)

SWAN KNIFE NEEDLE 1.5MM CAT # 1170

K-Number: K791981 · 1979-10-04

ApplicantEdward Weck, Inc.
Decision Date1979-10-04
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SWAN KNIFE NEEDLE 1.5MM CAT # 1170 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 1979-10-04 under 510(k) number K791981. The device is classified under product code HNN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWAN KNIFE NEEDLE 1.5MM CAT # 1170?

SWAN KNIFE NEEDLE 1.5MM CAT # 1170 is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Edward Weck, Inc.. The 510(k) number is K791981.

When did SWAN KNIFE NEEDLE 1.5MM CAT # 1170 receive FDA 510(k) clearance?

SWAN KNIFE NEEDLE 1.5MM CAT # 1170 received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791981.

Who is the listed applicant for SWAN KNIFE NEEDLE 1.5MM CAT # 1170?

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 SWAN KNIFE NEEDLE 1.5MM CAT # 1170?

The FDA product code for SWAN KNIFE NEEDLE 1.5MM CAT # 1170 is HNN.

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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: HNN)

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.

K110166CLEARCUT S SAFETY KNIFEAlcon Research, Ltd.K922378OPHTHALMIC KNIFEMicroptics Development LaboratoryK882402RETRACTIVE INCISION MICROMETER (RIM) GUAGEOptical CenterK881669MVR/STILETTO BLADE 20GA. - P/N 1900Advanced Surgical Products, Inc.K874979PRISMA DISPOSABLE MVR/STILETTO BLADEAdvanced Surgical Products, Inc.K874057OPHTHALMIC TIP & BLADE SCALPELSMyocure, Inc.

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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