MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies

MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies (Nevada): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies. Its amount of 115 is below the median of 138 (42nd percentile). Dated 21 days ago, it is in the active follow-up window. Score 41/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 115 · 42th percentile of 414 FDAPulse records · 0.8x the median

Free preview: all 14 published fields of this record are shown below. Locked: 1 related NV FDAPulse records and the 5-column CSV export.

FieldValue
Record510(k) clearance
510(k) numberK262097
DeviceMICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)
ApplicantCarl Zeiss Meditec Cataract Technologies
Specialty / panelOphthalmic
Product codeHQC
Device class2
Clearance typeSpecial
DecisionSubstantially Equivalent
Received2026-06-22
Decision date2026-10-15
Review time (days)115
Third-party reviewNo
Applicant locationReno, NV, US
amount percentile42th of 414 (median 138, 0.8x median)
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  • Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
  • Record date: 2026-10-15
  • Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies and 2 Nevada peers

  • Nevada FDAPulse records like this one: 2
  • MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies's amount: 42nd percentile of 414 records
  • Timing: Medium: dated in the last 30 days
  • Estimated pipeline if you contact every Nevada peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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41 / 100 Predicate Speed & CAPA Advisory Opportunity Score

  • Fast 115-day review: this device is a strong predicate for similar products.
  • Special 510(k): a modification of an existing device.
  • Posted 21 days ago.

What is the FDAPulse record for MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies in Nevada?

MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) by Carl Zeiss Meditec Cataract Technologies was cleared on 2026-10-15 after 115 days of review.

How does MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies compare to other Nevada FDAPulse records?

Its amount of 115 is below the median (42th percentile); smaller records often move faster and face less competition. It is 21 days old, still within a typical 45-day follow-up window.

MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) vs. top 3 peers

Compare MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) vs KOWA FM-600 (K261255) →

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