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FDA 510(k)

SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES

K-Number: K903303 · 1990-10-11

ApplicantSpembly Medical , Ltd.
Decision Date1990-10-11
Product CodeHPS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES is the device name listed in this FDA 510(k) record. The listed applicant is Spembly Medical , Ltd.. It received FDA 510(k) clearance on 1990-10-11 under 510(k) number K903303. The device is classified under product code HPS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES?

SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES is a medical device that received FDA 510(k) clearance on 1990-10-11. The listed applicant is Spembly Medical , Ltd.. The 510(k) number is K903303.

When did SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES receive FDA 510(k) clearance?

SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES received FDA 510(k) clearance on 1990-10-11, under 510(k) number K903303.

Who is the listed applicant for SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES?

The FDA 510(k) record lists Spembly Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES?

The FDA product code for SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES is HPS.

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Other records listing Spembly Medical , Ltd. 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.

K925129SELECTORK901974SELECTOR ULTRASONIC SURGICAL ASPIRATORK882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYK882963SPEMBLY MEDICAL 142 CRYO UNITK882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)K874367VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

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Related Devices (Code: HPS)

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.

K202038CryoTreQVitreQ BVK940373OPHTHALMIC CRYO UNITDutch Ophthalmic USA, Inc.K923629OPHTHALMIC TRICHIASIS PROBEMira, Inc.K874555KEELER ACU 22XT OPHTHALMIC CRYO UNITKeeler Instruments, Inc.K873388KEELER CTU CRYO SYSTEMKeeler Instruments, Inc.K870195UNITED SURGICAL CORP. CRYOPTIC PLUSUnited Surgical Corp.

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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