Suture Set or Laceration Trays (Packs)
FDA 510(k) K932219 · Associated Medical Products Co.
510(k) numberK932219
Submission
- Device name
- Suture Set or Laceration Trays (Packs)
- Applicant
- Associated Medical Products Co.
St. Louis Park, MN, US - Received
- May 7, 1993
- Decision date
- July 9, 1993
- Decision
- Unknown (SESK)
- 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
Other 510(k)s with product code KDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K924117 | Dexide Laparoscopic KitsKDD · Traditional | Dexide, Inc. | 03/23/1993SESK |
More from Dexide, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | 03/19/1997SE |
| K932216 | C-Section, Labor & Delivery Trays (Packs)MLS · Traditional | 04/19/1994SESK |
| K930507 | Custom Orthopaedic Trays (Packs)HTS · Traditional | 02/22/1994SE |
| K932217 | Major, Minor, Basin Trays (Packs)LRO · Traditional | 11/15/1993SESK |
| K932220 | Lap Choly Trays (Packs)LRO · Traditional | 09/27/1993SESK |
| K932218 | Cardiac Cath or Angiographic TraysDQO · Traditional | 08/27/1993SEKD |
| K842983 | Ampco Opthalmic TrayHOZ · Traditional | 05/22/1985SE |
| K843114 | Ampco Procedure Trays / Packs · Traditional | 08/08/1984SESP |
| K823839 | Ampco Kidney Dialysis TrayKOC · Traditional | 03/29/1983SE |
| K821579 | Skin Scrub-TrayLDR · Traditional | 07/21/1982SE |
Questions and answers
When was Suture Set or Laceration Trays (Packs) cleared by the FDA?
Suture Set or Laceration Trays (Packs) (K932219) received a 510(k) decision of Unknown on July 9, 1993, 63 days after the submission was received.
What is the product code of K932219?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.