MDM — Instrument, Manual, Surgical, General Use Class I
FDA Device Classification
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 |