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FDA 510(k)

SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2

K-Number: K102967 · 2010-11-04

ApplicantSmith & Newphew, Inc.
Decision Date2010-11-04
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Newphew, Inc.. It received FDA 510(k) clearance on 2010-11-04 under 510(k) number K102967. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2?

SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 is a medical device that received FDA 510(k) clearance on 2010-11-04. The listed applicant is Smith & Newphew, Inc.. The 510(k) number is K102967.

When did SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 receive FDA 510(k) clearance?

SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 received FDA 510(k) clearance on 2010-11-04, under 510(k) number K102967.

Who is the listed applicant for SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2?

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

What is the FDA product code for SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2?

The FDA product code for SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 is OLO.

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Other records listing Smith & Newphew, 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.

K101377SMITH & NEWPHEW ULTRABRAID II SUTURE

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Official Source

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