Laparoscopy Drape, Boundary
FDA 510(k) K772301 · Procter & Gamble Mfg. Co.
510(k) numberK772301
Submission
- Device name
- Laparoscopy Drape, Boundary
- Applicant
- Procter & Gamble Mfg. Co.
Mchenry, IL, US - Received
- December 14, 1977
- Decision date
- December 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZT – Cutter, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K112400 | SmartshearsFZT · Traditional | Nuscience Consulting and Management Group, LLC | 09/12/2011SE |
| K890818 | Auto Suture Disposable Surgical Trocar*FZT · Traditional | United States Surgical, A Division of Tyco Healthc | 05/04/1989SE |
| K872990 | Micrins Surgical ScissorFZT · Traditional | Micrins Surgical, Inc. | 08/17/1987SE |
| K841741 | Single Hair Transplant GraftFZT · Traditional | Paris Products, Inc. | 07/23/1984SE |
| K841247 | SPC Disposable CutterFZT · Traditional | Surgical Products Corp. | 05/02/1984SE |
| K822448 | Scissors, VariousFZT · Traditional | J. Sklar Mfg. Co., Inc. | 09/14/1982SE |
| K821632 | Surgical Scissors, Set of 3FZT · Traditional | Fred Sammons, Inc. | 06/24/1982SE |
| K821361 | Conphar Tonsil ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821355 | Conphar Littauer ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821352 | Conphar Iris ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
More from Conphar, Inc.
| 510(k) | Device | Decision |
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| K873036 | Attends Incontinent BriefEYQ · Traditional | 01/19/1988SE |
| K864673 | Unscented Menstrual PadHHL · Traditional | 01/21/1987SE |
| K861863 | Modified Protective GarmentEYQ · Traditional | 08/11/1986SE |
| K862348 | Single-Use Patient UnderpadKME · Traditional | 07/02/1986SE |
| K860598 | Modified Protective Garment for IncontinentsEYQ · Traditional | 03/05/1986SE |
| K853880 | Attends Dispos. UnderpadKME · Traditional | 10/16/1985SE |
| K853000 | Scented Always PantilinersHHL · Traditional | 09/06/1985SE |
| K852985 | Unscented Always PantilinersHHD · Traditional | 08/29/1985SE |
| K850956 | Always Maxipads - ScentedHHL · Traditional | 05/14/1985SE |
Questions and answers
When was Laparoscopy Drape, Boundary cleared by the FDA?
Laparoscopy Drape, Boundary (K772301) received a 510(k) decision of Substantially Equivalent on December 20, 1977, 6 days after the submission was received.
What is the product code of K772301?
The FDA product code is FZT – Cutter, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.