Sterile Dissector Sponges-X-Ray Detect
FDA 510(k) K812707 · Medspec Corp.
510(k) numberK812707
Submission
- Device name
- Sterile Dissector Sponges-X-Ray Detect
- Applicant
- Medspec Corp.
Mchenry, IL, US - Received
- September 24, 1981
- Decision date
- November 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDY – Gauze/Sponge, Internal, X-Ray Detectable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4450
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972634 | Ultracell Suction SpongeGDY · Traditional | Ultracell Medical Technologies, Inc. | 12/17/1997SE |
| K960236 | CPR Lap SpongesGDY · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K955599 | Stryker Femoral Canal Sponge & Acetabulum SpongeGDY · Traditional | Stryker Corp. | 02/22/1996SE |
| K955322 | Protec X-Ray Detectable Gauze SpongeGDY · Traditional | Derivados DE Gasa, S.A. DE C.V. | 12/19/1995SE |
| K953830 | KensorbGDY · Traditional | Kentron Health Care, Inc. | 10/03/1995SE |
| K953088 | Triangular SpongesGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953087 | Cherry Pit DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953062 | Cherry DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953060 | Rosebud DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953059 | Kittner DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
More from Medical Perspectives Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K813012 | Sterile Basin SetsLDQ · Traditional | 11/06/1981SE |
| K812711 | Sterile Gauze Pads 12PLYNAB · Traditional | 11/02/1981SE |
| K812710 | Sterile Laparotomy Sponges-X-Ray DetectGDY · Traditional | 11/02/1981SE |
| K812709 | Sterile Dental RollEFN · Traditional | 10/23/1981SE |
| K810071 | Sterile Silicone TubingGBS · Traditional | 02/12/1981SE |
| K810069 | Sterile AirwayCAE · Traditional | 02/02/1981SE |
| K802060 | Sterile Tonsil SpongesGDY · Traditional | 10/10/1980SE |
| K801069 | Sterile Isolation GownFYC · Traditional | 05/20/1980SE |
| K801068 | Sterile Abdominal PadKKX · Traditional | 05/20/1980SE |
| K800279 | Medspec Rubber Bands · Traditional | 05/02/1980SE |
Questions and answers
When was Sterile Dissector Sponges-X-Ray Detect cleared by the FDA?
Sterile Dissector Sponges-X-Ray Detect (K812707) received a 510(k) decision of Substantially Equivalent on November 2, 1981, 39 days after the submission was received.
What is the product code of K812707?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.