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FDA 510(k)

CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM

K-Number: K761253 · 1976-12-16

ApplicantEdward Weck, Inc.
Decision Date1976-12-16
Product CodeHND
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM 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 1976-12-16 under 510(k) number K761253. 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 CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM?

CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM is a medical device that received FDA 510(k) clearance on 1976-12-16. The listed applicant is Edward Weck, Inc.. The 510(k) number is K761253.

When did CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM receive FDA 510(k) clearance?

CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM received FDA 510(k) clearance on 1976-12-16, under 510(k) number K761253.

Who is the listed applicant for CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM?

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 CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM?

The FDA product code for CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM 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.K801608MCCULLEY CONTINUOUS SUTURE TIGHTNEREdward Weck, Inc.K791983SPATULA'S #'S 7618,7248,7240,7242,5108Edward 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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