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FDA 510(k)

MAX-I-PROBE IRRIGATION SYSTEM

K-Number: K913030 · 1991-09-30

ApplicantSmith & Nephew, Inc.
Decision Date1991-09-30
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAX-I-PROBE IRRIGATION SYSTEM 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 1991-09-30 under 510(k) number K913030. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAX-I-PROBE IRRIGATION SYSTEM?

MAX-I-PROBE IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1991-09-30. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K913030.

When did MAX-I-PROBE IRRIGATION SYSTEM receive FDA 510(k) clearance?

MAX-I-PROBE IRRIGATION SYSTEM received FDA 510(k) clearance on 1991-09-30, under 510(k) number K913030.

Who is the listed applicant for MAX-I-PROBE IRRIGATION SYSTEM?

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 MAX-I-PROBE IRRIGATION SYSTEM?

The FDA product code for MAX-I-PROBE IRRIGATION SYSTEM is EFS.

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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: EFS)

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.

K023232SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLESmartpracticeK001493DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001Air Force, Inc.K983374AGATHA-A-H2010Midian Intl.K964810DERMADAMUltradent Products, Inc.K952234BARRIER ALL FILMCottrell, Ltd.K943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOROral-B Laboratories

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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