Surgical Instrument Kit, Disposable
FDA 510(k) K920989 · Ulti-Med Intl., Inc.
510(k) numberK920989
Submission
- Device name
- Surgical Instrument Kit, Disposable
- Applicant
- Ulti-Med Intl., Inc.
Glendale Hts., IL, US - Received
- March 2, 1992
- Decision date
- October 19, 1992
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional | Covidien | 04/16/2008SE |
| K011514 | Instruments for One Time Use - DisposableKDD · Traditional | Kencap , Ltd. | 08/13/2001SE |
| K971317 | National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional | National Healthcare Mfg. Corp. | 05/08/1997SE |
| K960456 | Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional | Denver Biomaterials, Inc. | 04/01/1996SE |
| K936255 | Custom CV PackKDD · Traditional | Associated Medical | 03/31/1994SN |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | Associated Medical Products Co. | 07/09/1993SESK |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K925905 | Kit, Surgical Instrument, DisposableKDD · Traditional | Kay Medical Concepts | 06/16/1993SESK |
| K924958 | Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional | Medical Insights, Inc. | 06/07/1993SEKD |
| K925215 | Sterile Surgical Instrument TraysKDD · Traditional | American Healthcare Supply Co., Inc. | 06/01/1993SEKD |
More from American Healthcare Supply Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K103011 | Ulticare Safety Insulin SyringeMEG · Traditional | 02/02/2011SE |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | 06/17/1993SE |
| K923175 | Surgical Instrument Kit, DisposableFMC · Traditional | 06/17/1993SE |
| K922828 | Ulcer Wound TrayKKX · Traditional | 09/28/1992SEKD |
| K914244 | Sterile Custom Surgical KitsKDD · Traditional | 02/24/1992SEKD |
| K914431 | Absorbent FiberNAB · Traditional | 12/04/1991SE |
| K912693 | Post Operative SpongeNAB · Traditional | 10/04/1991SE |
| K912692 | Conforming BandageNAB · Traditional | 10/04/1991SE |
| K904896 | Eye PadHMP · Traditional | 12/05/1990SE |
| K901465 | Absorbable Gauze DrapeKKX · Traditional | 06/12/1990SE |
Questions and answers
When was Surgical Instrument Kit, Disposable cleared by the FDA?
Surgical Instrument Kit, Disposable (K920989) received a 510(k) decision of Unknown on October 19, 1992, 231 days after the submission was received.
What is the product code of K920989?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.