Sterile Suture Removal Kit
FDA 510(k) K771448 · Premium Plastics, Inc.
510(k) numberK771448
Submission
- Device name
- Sterile Suture Removal Kit
- Applicant
- Premium Plastics, Inc.
Mchenry, IL, US - Received
- August 2, 1977
- Decision date
- September 6, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K953226 | Pulm O2 Suction Catheter TraysBSY · Traditional | 08/08/1995SE |
| K950851 | Gent-L-Kare Tracheostomy TraysLRQ · Traditional | 06/21/1995SE |
| K950850 | Gent-L-Kare Laceration TraysFRG · Traditional | 03/14/1995SN |
| K943740 | Roll-A-Way Sharps Disposal System (Red and Ivory)FMI · Traditional | 12/14/1994SE |
| K890107 | Gent-L-Kare(Tm) Sterile, Pressure Sore Manage KitFRO · Traditional | 10/24/1989SESD |
| K893135 | Gent-L-Kare Ster Suct Cath Tray W/14 Fr/Ster WaterJOL · Traditional | 06/22/1989SE |
| K850285 | Gent-L-Kare Sterile Urethral Catheterization TrayKOD · Traditional | 02/28/1985SE |
| K800440 | Sterile Sponge BowlsFNY · Traditional | 04/29/1980SE |
Questions and answers
When was Sterile Suture Removal Kit cleared by the FDA?
Sterile Suture Removal Kit (K771448) received a 510(k) decision of Substantially Equivalent on September 6, 1977, 35 days after the submission was received.
What is the product code of K771448?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.