About This 510(k) Submission
K120898 is an FDA 510(k) clearance for the KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA, a Laparoscopic Single Port Access Device (Class II — Special Controls, product code OTJ), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on August 3, 2012, 130 days after receiving the submission on March 26, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.