Lancer Biopsy Holder
FDA 510(k) K772149 · Sherwood Medical Industries
510(k) numberK772149
Submission
- Device name
- Lancer Biopsy Holder
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- November 14, 1977
- Decision date
- November 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KER
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831922 | Embedding RingKER · Traditional | Polymer Technology Corp. | 07/29/1983SE |
| K831900 | Maclean-Fogg, Disp. Base MoldKER · Traditional | Polymer Technology Corp. | 07/28/1983SE |
| K831333 | Embedding RingsKER · Traditional | Surgipath Medical Industries, Inc. | 05/25/1983SE |
| K831335 | Disposable Base MoldKER · Traditional | Surgipath Medical Industries, Inc. | 05/16/1983SE |
More from Surgipath Medical Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | 07/21/1980SE |
| K801071 | Lancer Glucose Rate Reagent KitCGA · Traditional | 05/23/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | 11/13/1979SE |
| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K782077 | Lancer Ice CubeJRM · Traditional | 04/03/1979SE |
| K790523 | Argyle Esophageal StethoscopeBZW · Traditional | 03/27/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
| K781060 | Monoject Endosseous Dental ImplantDZE · Traditional | 08/14/1978SE |
Questions and answers
When was Lancer Biopsy Holder cleared by the FDA?
Lancer Biopsy Holder (K772149) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 8 days after the submission was received.
What is the product code of K772149?
The FDA product code is KER – Container, Embedding, a Class I (low risk) device regulated under 21 CFR 864.3010.