MDM — Instrument, Manual, Surgical, General Use Class I
FDA product code MDM covers "Instrument, Manual, Surgical, General Use", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MDM
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K073664 | injectimed | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | August 8, 2008 |
| K050575 | futumeds | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | August 15, 2005 |
| K050957 | special devices | EUTROCHAR | May 18, 2005 |
| K023173 | andrews surgical innovations | ANDREWS INTRODUCER, MODEL ASI01 | December 18, 2002 |
| K022059 | boston scientific | MICROVASIVE PULMONARY GUIDEWIRE | November 13, 2002 |
| K013040 | minrad | LIGHT SABER INTRODUCER NEEDLE | December 7, 2001 |
| K010184 | canica design | CHESS HAND SURGERY SYSTEM | June 22, 2001 |
| K990062 | genzyme surgical product (genzyme biosurgery) | SAPHLIFT | March 30, 1999 |
| K981579 | ethicon | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | July 9, 1998 |
| K943968 | denver biomedicals | TUNNELER | March 1, 1995 |
| K945430 | hasting biomedical | DERMAVBLADE(TM) | November 28, 1994 |
| K941193 | east west instruments | EAST WEST INSTRUMENTS | November 9, 1994 |
| K941907 | apex ent | APEX DISPOSABLE INSTRUMENTS | August 26, 1994 |
| K942818 | automated medical products | DEEP SUTURE | August 25, 1994 |
| K942896 | surgin surgical instrumentation | CLAMPS AND CLIPS | July 19, 1994 |
| K940684 | her-mar | SURGICAL INSTRUMENT, DISPOSABLE | March 14, 1994 |
| K933265 | acuderm | ACU-DISPO-CE(TM) | March 7, 1994 |
| K933866 | acuderm | ACU-HEMOSTATIC RING | December 1, 1993 |
| K925653 | dermatopathology laboratory | DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH | November 8, 1993 |
| K922130 | savoy medical supply co | HOSPITAL KIT DK 117 | May 24, 1993 |