Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep Tray

FDA 510(k) K924958 · Medical Insights, Inc.

Unknown

510(k) numberK924958

Submission

Device name
Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep Tray
Applicant
Medical Insights, Inc.
Mystic, CT, US
Received
September 30, 1992
Decision date
June 7, 1993
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
K925215Sterile Surgical Instrument TraysKDD · Traditional American Healthcare Supply Co., Inc.06/01/1993SEKD
K924117Dexide Laparoscopic KitsKDD · Traditional Dexide, Inc.03/23/1993SESK

More from Dexide, Inc.

510(k)DeviceDecision
K940904Kittner Dissector/Peanut/Cherry/Stick/Triangle Sponge/Gauze RosebudEFQ · Traditional 04/14/1994SE
K940903Tonsil Sponge, Gauze Dissector, Cylindrical SpongesKBM · Traditional 04/14/1994SE
K940901Non-Woven SpongeEFQ · Traditional 03/31/1994SE

Questions and answers

When was Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep Tray cleared by the FDA?

Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep Tray (K924958) received a 510(k) decision of Unknown on June 7, 1993, 250 days after the submission was received.

What is the product code of K924958?

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