Company ยท US
Sterile Concepts, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1995. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LRO | General Surgery Tray | 2 |
| EIA | Unit, Operative Dental | 1 |
| FRG | Wrap, Sterilization | 1 |
| GAN | Suture, Absorbable, Synthetic | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 |
| LYY | Latex Patient Examination Glove | 1 |
| MCZ | Suture Removal Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 1, 1995 | K951231 | ORTHOPEDIC PACKS Sterile Concepts, Inc. | GAN |
| Nov 13, 1995 | K951081 | OB/GYN PACKS Sterile Concepts, Inc. | KNA |
| Jul 14, 1995 | K952539 | RADIOLOGY PACKS Sterile Concepts, Inc. | LRO |
| Jun 13, 1995 | K951478 | GENERAL AND PLASTIC SURGERY PACKS Sterile Concepts, Inc. | LRO |
| Dec 15, 1994 | K944139 | DENTAL HYGIENE TRAY Sterile Concepts, Inc. | LYY |
| Sep 14, 1994 | K943047 | IV START KITS Sterile Concepts, Inc. | KMK |
| Aug 22, 1994 | K943090 | SUTURE REMOVAL TRAYS Sterile Concepts, Inc. | FRG |
| Aug 2, 1994 | K940864 | DENTIST WITH ASSISTANT PACK Sterile Concepts, Inc. | EIA |
| Jul 29, 1994 | K943046 | SKIN STAPLE REMOVAL TRAYS Sterile Concepts, Inc. | MCZ |
| Sep 28, 1992 | K920763 | LACERATTION TRAY Sterile Concepts, Inc. | KDD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||