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FDA 510(k)

MCCULLEY CONTINUOUS SUTURE TIGHTNER

K-Number: K801608 · 1980-08-12

ApplicantEdward Weck, Inc.
Decision Date1980-08-12
Product CodeHND
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MCCULLEY CONTINUOUS SUTURE TIGHTNER 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 1980-08-12 under 510(k) number K801608. The device is classified under product code HND. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCCULLEY CONTINUOUS SUTURE TIGHTNER?

MCCULLEY CONTINUOUS SUTURE TIGHTNER is a medical device that received FDA 510(k) clearance on 1980-08-12. The listed applicant is Edward Weck, Inc.. The 510(k) number is K801608.

When did MCCULLEY CONTINUOUS SUTURE TIGHTNER receive FDA 510(k) clearance?

MCCULLEY CONTINUOUS SUTURE TIGHTNER received FDA 510(k) clearance on 1980-08-12, under 510(k) number K801608.

Who is the listed applicant for MCCULLEY CONTINUOUS SUTURE TIGHTNER?

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 MCCULLEY CONTINUOUS SUTURE TIGHTNER?

The FDA product code for MCCULLEY CONTINUOUS SUTURE TIGHTNER is HND.

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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: HND)

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.

K863990THORNTON TITANIUM SILVER SPATULAKeeler Instruments, Inc.K810937ANIS IRRIGATING SPATULAAmerican V. MuellerK801609MADDOX LENS SPATULA CAT. #7245Edward Weck, Inc.K791983SPATULA'S #'S 7618,7248,7240,7242,5108Edward Weck, Inc.K761253CYCLODIALYSIS SPAT. 15MM BLADE TITANIUMEdward Weck, 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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