Surgical Instrument Pouch #M102
FDA 510(k) K891213 · Pro-Safe Professional Linens, Inc.
510(k) numberK891213
Submission
- Device name
- Surgical Instrument Pouch #M102
- Applicant
- Pro-Safe Professional Linens, Inc.
Grand Junction, CO, US - Received
- March 7, 1989
- Decision date
- April 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code KCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K253187 | SteriBest® Sterilization Tray SystemKCT · Traditional | Mastel Surgical | 06/18/2026SE |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | Case Medical, Inc. | 06/03/2026SE |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 02/06/2026SE |
| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 07/22/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
More from Talladium España, SL
| 510(k) | Device | Decision |
|---|---|---|
| K891210 | Pocketed Wraps #3009 A,B,CKCT · Traditional | 10/13/1989SE |
| K891216 | Dental Equipment Protection DevicesEAZ · Traditional | 06/02/1989SE |
| K891215 | Fast Wrap #M 101KCT · Traditional | 04/14/1989SE |
| K891214 | Dental Surgical Wrap #3007 A,B,CKCT · Traditional | 04/14/1989SE |
| K891212 | Aprons, Scrubs Slacks & Tops, Patient DrapeFXO · Traditional | 04/14/1989SE |
| K891211 | Surgical Gown #2001FYA · Traditional | 04/14/1989SE |
Questions and answers
When was Surgical Instrument Pouch #M102 cleared by the FDA?
Surgical Instrument Pouch #M102 (K891213) received a 510(k) decision of Substantially Equivalent on April 14, 1989, 38 days after the submission was received.
What is the product code of K891213?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.