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FDA 510(k)

T-TUBE INSERTER

K-Number: K870978 · 1987-03-19

ApplicantSur-Med Instruments, Inc.
Decision Date1987-03-19
Product CodeJYM
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

T-TUBE INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Sur-Med Instruments, Inc.. It received FDA 510(k) clearance on 1987-03-19 under 510(k) number K870978. The device is classified under product code JYM. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-TUBE INSERTER?

T-TUBE INSERTER is a medical device that received FDA 510(k) clearance on 1987-03-19. The listed applicant is Sur-Med Instruments, Inc.. The 510(k) number is K870978.

When did T-TUBE INSERTER receive FDA 510(k) clearance?

T-TUBE INSERTER received FDA 510(k) clearance on 1987-03-19, under 510(k) number K870978.

Who is the listed applicant for T-TUBE INSERTER?

The FDA 510(k) record lists Sur-Med Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T-TUBE INSERTER?

The FDA product code for T-TUBE INSERTER is JYM.

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Other records listing Sur-Med Instruments, 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.

K903401SPECIAL RONGEURK870897KODNER ANAL PERIONEAL RETRACTOR

Related Devices (Code: JYM)

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.

K924901DEANS DISPOSABLE T-TUBE INSERTERExmoor Plastics , Ltd.K822349ARMSTRONG V TUBE SUCTION INSERTERTreace Medical, Inc.K822348TYTAN TUBE INSERTERTreace Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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