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FDA 510(k)

INFINITECH SOFT TIP FLUTE NEEDLE

K-Number: K946181 · 1995-03-14

ApplicantSurgical Technologies, Inc.
Decision Date1995-03-14
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INFINITECH SOFT TIP FLUTE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1995-03-14 under 510(k) number K946181. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITECH SOFT TIP FLUTE NEEDLE?

INFINITECH SOFT TIP FLUTE NEEDLE is a medical device that received FDA 510(k) clearance on 1995-03-14. The listed applicant is Surgical Technologies, Inc.. The 510(k) number is K946181.

When did INFINITECH SOFT TIP FLUTE NEEDLE receive FDA 510(k) clearance?

INFINITECH SOFT TIP FLUTE NEEDLE received FDA 510(k) clearance on 1995-03-14, under 510(k) number K946181.

Who is the listed applicant for INFINITECH SOFT TIP FLUTE NEEDLE?

The FDA 510(k) record lists Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITECH SOFT TIP FLUTE NEEDLE?

The FDA product code for INFINITECH SOFT TIP FLUTE NEEDLE is HQE.

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Other records listing Surgical Technologies, 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.

K941992CYSTOSCOPEK942029ARTHROSCOPEK946136INFINITECH LIGHTED INFUSION CANNULAK952566OSCILFLATORK951918SURGICAL TECHNOLOGIES, INC. SYRINGEK950683ARTHROGRAM TRAY

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Related Devices (Code: HQE)

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.

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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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