Precision Glide - Enhanced Surgical Blade
FDA 510(k) K911913 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK911913
Submission
- Device name
- Precision Glide - Enhanced Surgical Blade
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- April 30, 1991
- Decision date
- May 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GES – Blade, Scalpel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GES
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032242 | Personna Plus Safety Scalpel SystemGES · Traditional | Omi Manufacturing Pty., Ltd. | 09/23/2003SE |
| K932998 | Easy-OnGES · Traditional | Devon Industries, Inc. | 08/18/1993SE |
| K923170 | Los Alamos Retractable KnifeGES · Traditional | Innovative Surgical Technology, Inc. | 02/18/1993SE |
| K915119 | Scalpel Blade Remover (Bladegard)GES · Traditional | Intergrated Visual, Inc. | 05/05/1992SE |
| K900266 | Sterile Carbon Steel Surgical BladeGES · Traditional | Rahn Laboratories | 03/01/1990SE |
| K884862 | Anchor Double-Edge Myringotomy BladeGES · Traditional | Anchor Products Co. | 12/27/1988SE |
| K881638 | Surgical BladeGES · Traditional | Far East Intl. Trading Corp. | 06/15/1988SE |
| K880244 | Surgical BladesGES · Traditional | Ailee C/O Havel'S, Inc. | 02/10/1988SE |
| K873493 | Ninja ScalpelGES · Traditional | Primrose Medical, Inc. | 09/24/1987SE |
| K873142 | Personna Disposable ScalpelGES · Traditional | American Safety Razor Co. | 09/04/1987SE |
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| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
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Questions and answers
When was Precision Glide - Enhanced Surgical Blade cleared by the FDA?
Precision Glide - Enhanced Surgical Blade (K911913) received a 510(k) decision of Substantially Equivalent on May 13, 1991, 13 days after the submission was received.
What is the product code of K911913?
The FDA product code is GES – Blade, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.