Sterile Custom Surgical Kits

FDA 510(k) K914244 · Ulti-Med Intl., Inc.

Unknown

510(k) numberK914244

Submission

Device name
Sterile Custom Surgical Kits
Applicant
Ulti-Med Intl., Inc.
Glendale Hts., IL, US
Received
September 23, 1991
Decision date
February 24, 1992
Decision
Unknown (SEKD)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KDD – Kit, Surgical Instrument, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code KDD

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K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional Covidien04/16/2008SE
K011514Instruments for One Time Use - DisposableKDD · Traditional Kencap , Ltd.08/13/2001SE
K971317National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional National Healthcare Mfg. Corp.05/08/1997SE
K960456Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional Denver Biomaterials, Inc.04/01/1996SE
K936255Custom CV PackKDD · Traditional Associated Medical03/31/1994SN
K932219Suture Set or Laceration Trays (Packs)KDD · Traditional Associated Medical Products Co.07/09/1993SESK
K923176Surgical Instrument Kit, DisposableKDD · Traditional Ulti-Med Intl., Inc.06/17/1993SE
K925905Kit, Surgical Instrument, DisposableKDD · Traditional Kay Medical Concepts06/16/1993SESK
K924958Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional Medical Insights, Inc.06/07/1993SEKD
K925215Sterile Surgical Instrument TraysKDD · Traditional American Healthcare Supply Co., Inc.06/01/1993SEKD

More from American Healthcare Supply Co., Inc.

510(k)DeviceDecision
K103011Ulticare Safety Insulin SyringeMEG · Traditional 02/02/2011SE
K923176Surgical Instrument Kit, DisposableKDD · Traditional 06/17/1993SE
K923175Surgical Instrument Kit, DisposableFMC · Traditional 06/17/1993SE
K920989Surgical Instrument Kit, DisposableKDD · Traditional 10/19/1992SEKD
K922828Ulcer Wound TrayKKX · Traditional 09/28/1992SEKD
K914431Absorbent FiberNAB · Traditional 12/04/1991SE
K912693Post Operative SpongeNAB · Traditional 10/04/1991SE
K912692Conforming BandageNAB · Traditional 10/04/1991SE
K904896Eye PadHMP · Traditional 12/05/1990SE
K901465Absorbable Gauze DrapeKKX · Traditional 06/12/1990SE

Questions and answers

When was Sterile Custom Surgical Kits cleared by the FDA?

Sterile Custom Surgical Kits (K914244) received a 510(k) decision of Unknown on February 24, 1992, 154 days after the submission was received.

What is the product code of K914244?

The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.