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FDA 510(k)

FLUORETS STERILE OPHTH. STRIPS

K-Number: K831621 · 1983-07-18

ApplicantSmith & Nephew, Inc.
Decision Date1983-07-18
Product CodeKYC
DecisionSubstantially Equivalent

Device Summary

FLUORETS STERILE OPHTH. STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1983-07-18 under 510(k) number K831621. The device is classified under product code KYC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORETS STERILE OPHTH. STRIPS?

FLUORETS STERILE OPHTH. STRIPS is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K831621.

When did FLUORETS STERILE OPHTH. STRIPS receive FDA 510(k) clearance?

FLUORETS STERILE OPHTH. STRIPS received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831621.

Who is the listed applicant for FLUORETS STERILE OPHTH. STRIPS?

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

What is the FDA product code for FLUORETS STERILE OPHTH. STRIPS?

The FDA product code for FLUORETS STERILE OPHTH. STRIPS is KYC.

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Other records listing Smith & Nephew, 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.

K261462LANDMARK Total Knee SystemK261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC GlenoidsK252416AETOS Shoulder System Meta Humeral Prosthesis Size 0K252129AETOS Shoulder System Stemless Humeral ProsthesisK251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: KYC)

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.

K810285BARNES-HIND ROSE BENGAL OPHTHALMIC STR.Barnes-Hind, Inc.K780125FLUORESOFTHolles Laboratories, 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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